immunogenicity and safety of a trivalent inactivated influenza vaccine, formulation 2010-2011, in healthy subjects aged over 6 months old to 18 years old

Conditions: Influenza

Summary: this is an open study of the use of adimflu-s (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. all participants will be divided into three age cohorts. first, participants aged 6 through \< 36 months will receive 2 doses of 0.25 ml vaccine separated by 4 weeks. second, participants aged 3 through \< 9 years will receive 2 doses of 0.5 ml vaccine separated by 4 weeks. third, participants aged 9 through \< 18 years will receive one dose of 0.5 ml vaccine. safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events, and serious adverse events. sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each vaccination. anti-hemaglutinin (ha) antibody titers will be determined using the who haemaglutination inhibition reference technique. the analysis will be observer-blinded. all participants will be followed, either by clinical visit or by telephone contact, for 6 months after the first vaccination for safety reasons.


Eligibility criteria:
inclusion criteria: * boys or girls and aged 6 months old to 18 years old on the day of first vaccination; * subject and/or parents(s)/legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits; * subject must be in good physical health on the basis of medical history, physical examination; * subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure. exclusion criteria: * subjects received influenza vaccine (trivalent and/or a(h1n1)) within the previous 6 months; * history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication; * personal or family history of guillain-barré syndrome; * an acute febrile illness within 1 week prior to vaccination; * current upper respiratory illness (uri), including the common cold or nasal congestion within 72 hours; * subjects with influenza-like illness as defined by the presence of fever (temperature ³38ºc) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough; * female subjects who are pregnant, lactating or likely to become pregnant during the study; women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, iud, barrier device or abstinence) throughout the study; * treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; * immunodeficiency, immunosuppressive or household contact with immunosuppression; * history of wheezing or bronchodilator use within 3 months prior to study vaccine; * receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation; * receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation; * receipt of any blood products, including immunoglobulin in the prior 3 months; * underlying condition in the investigators' opinion may interfere with evaluation of the vaccine; * significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

Keywords: influenza vaccine immunogenicity